OBJECTIVE: This study examined whether physicians with varying carotid stent experience would obtain safety and efficacy outcomes as good as those from the pivotal SAPPHIRE trial following participation in a comprehensive carotid stent training program. BACKGROUND: This study was performed as a condition of approval study for the PRECISE(R) Nitinol Stent and the ANGIOGUARD XP Emboli Capture Guidewire. METHODS: Patients at high surgical risk who were either symptomatic with >or=50% stenosis or asymptomatic with >or=80% stenosis of the common or internal carotid artery received carotid artery stenting with distal emboli protection using the PRECISE Nitinol Stent and the ANGIOGUARD XP Emboli Capture Guidewire. Physicians were qualified based on either prior experience in carotid stenting with the ANGIOGUARD XP Emboli Capture Guidewire or following participation in a formal training program. The primary endpoint of major adverse events (MAE) at 30 days (death, myocardial infarction (MI), or stroke) was tested for non-inferiority compared with an objective performance criterion (OPC) of 6.3% established from the stent cohort of the SAPPHIRE trial. RESULTS: The 30-day MAE rate was 5.0%, meeting the criteria for non-inferiority to the prespecified OPC (95% CI [3.9%, 6.2%] P<0.001). Asymptomatic patients (N=1,158, 78.2%) had similar outcomes to the overall results (MAE 4.7%). Outcomes were similar across levels of physician experience, carotid stent volume, geographic location, presence/absence of training program. CONCLUSIONS: Utilizing a comprehensive training program, carotid artery stenting by operators with differing experience in a variety of practice settings yielded safety and efficacy outcomes similar to those reported in the SAPPHIRE trial. Copyright (c) 2007 Wiley-Liss, Inc.
OBJECTIVE: This study examined whether physicians with varying carotid stent experience would obtain safety and efficacy outcomes as good as those from the pivotal SAPPHIRE trial following participation in a comprehensive carotid stent training program. BACKGROUND: This study was performed as a condition of approval study for the PRECISE(R) Nitinol Stent and the ANGIOGUARD XP Emboli Capture Guidewire. METHODS:Patients at high surgical risk who were either symptomatic with >or=50% stenosis or asymptomatic with >or=80% stenosis of the common or internal carotid artery received carotid artery stenting with distal emboli protection using the PRECISE Nitinol Stent and the ANGIOGUARD XP Emboli Capture Guidewire. Physicians were qualified based on either prior experience in carotid stenting with the ANGIOGUARD XP Emboli Capture Guidewire or following participation in a formal training program. The primary endpoint of major adverse events (MAE) at 30 days (death, myocardial infarction (MI), or stroke) was tested for non-inferiority compared with an objective performance criterion (OPC) of 6.3% established from the stent cohort of the SAPPHIRE trial. RESULTS: The 30-day MAE rate was 5.0%, meeting the criteria for non-inferiority to the prespecified OPC (95% CI [3.9%, 6.2%] P<0.001). Asymptomatic patients (N=1,158, 78.2%) had similar outcomes to the overall results (MAE 4.7%). Outcomes were similar across levels of physician experience, carotid stent volume, geographic location, presence/absence of training program. CONCLUSIONS: Utilizing a comprehensive training program, carotid artery stenting by operators with differing experience in a variety of practice settings yielded safety and efficacy outcomes similar to those reported in the SAPPHIRE trial. Copyright (c) 2007 Wiley-Liss, Inc.